Does Saxenda affect mental health?

Chronic Weight Management: In adult clinical trials, 0.3% (9/3384) of patients receiving liraglutide (the active ingredient contained in Saxenda) reported suicidal ideation (placebo=0.1% [2/1941]) and 1 attempted suicide.

drugs.com - Saxenda Side Effects: Common, Severe, Long Term - Drugs.com

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Saxenda Side Effects

Generic name: liraglutide

Medically reviewed by Drugs.com. Last updated on Jun 27, 2022.

Note: This document contains side effect information about liraglutide. Some dosage forms listed on this page may not apply to the brand name Saxenda.

Applies to liraglutide: subcutaneous solution.

Warning Subcutaneous route (Solution) Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined.Liraglutide is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of liraglutide and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide.

Serious side effects of Saxenda

Along with its needed effects, liraglutide (the active ingredient contained in Saxenda) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur while taking liraglutide:

More common

Bladder pain

bloody or cloudy urine

chills

cough

diarrhea

difficult, burning, or painful urination

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

hoarseness

joint pain

loss of appetite

lower back or side pain

muscle aches and pains

nausea

runny nose

shivering

sore throat

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Less common

Blurred vision

dizziness

nervousness

pounding in the ears

slow or fast heartbeat

Rare

Anxiety

cold sweats

confusion

cool, pale skin

depression

hives or welts, itching, or skin rash

increased hunger

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

loss of consciousness

nightmares

redness of the skin

seizures

shakiness

slurred speech

Incidence not known

Agitation

clay-colored stools

confusion

dark urine

decreased awareness or responsiveness

decreased urine output

depression

difficulty with swallowing

hostility

irritability

muscle twitching

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

severe sleepiness

swelling of the face, ankles, or hands

tightness in the chest

unpleasant breath odor

vomiting of blood

yellow eyes or skin

Other side effects of Saxenda

Some side effects of liraglutide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

belching

body aches or pain

constipation

decreased appetite

heartburn

indigestion

loss of voice

pain or tenderness around the eyes and cheekbones

sneezing

stomach cramps, discomfort, or pain

stuffy nose

swollen mouth and tongue

unpleasant taste

urge to have bowel movement

weight loss

Less common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to liraglutide: subcutaneous solution.

Gastrointestinal

Chronic Weight Management:

Very common (10% or more): Nausea (39.3%), diarrhea (20.9%), constipation (19.4%), vomiting (15.7%), Common (1% to 10%): Dyspepsia, abdominal pain, upper abdominal pain, gastroesophageal reflux disease, abdominal distension, eructation, flatulence, dry mouth, gastroenteritis, viral gastroenteritis, increased lipase

Uncommon (0.1% to 1%): Acute pancreatitis, acute gallbladder disease

Type 2 Diabetes Mellitus:

Very common (10% or more): Nausea (up to 28.4%), diarrhea (up to 17.1%), vomiting (up to 10.9%) Common (1% to 10%): Constipation, dyspepsia, abdominal pain, gastritis, flatulence, abdominal discomfort, toothache, elevated lipase, elevated amylase

Rare (less than 0.1%): Intestinal obstruction

Postmarketing reports: Acute hemorrhagic or necrotizing pancreatitis, including fatalities[Ref]

Chronic Weight Management:

-The percentage of patients reporting nausea declined as treatment continued. Most gastrointestinal events were mild or moderate and did not lead to discontinuation. -Acute pancreatitis occurred in 0.3% (9/3291) of liraglutide-treated patients and 0.1% (1/1843) of placebo patients in clinical trials. Three additional cases occurred in liraglutide-treated patients, 2 in patients who prematurely withdrew from the trial and 1 during an off-treatment follow-up period. In a pediatric clinical trial, 1 patient reported pancreatitis.

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-Acute gallbladder disease was reported more frequently in liraglutide-treated patients (1.5% versus 0.5%) during clinical trials. Substantial or rapid weight loss can increase the risk of cholelithiasis, but even after accounting for the degree of weight loss, the incidence of acute gallbladder disease was greater in liraglutide-treated patients.

Type 2 Diabetes Mellitus

-Postmarketing reports of acute hemorrhagic or necrotizing pancreatitis, including fatalities have been reported. During clinical trials, 13 cases of pancreatitis were received among liraglutide treated patients, 9 acute and 4 chronic compared with 1 case in the comparator (glimepiride) group; some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. -Serum amylase and lipase were routinely measure in the LEADER trial; elevations of 3 times the upper limit of normal were reported in 1% and 7.5% of liraglutide treated patients compared with 0.7 % and 4.5% of placebo, respectively. -In the LEADER trial, 3.1% of liraglutide treated patients reported an acute event of gallbladder disease such as cholelithiasis or cholecystitis.[Ref]

Metabolic

Chronic Weight Management:

Very common (10% or more): Hypoglycemia (Type 2 diabetes [23%])

Common (1% to 10%): Decreased appetite; hypoglycemia (pediatric)

Type 2 Diabetes Mellitus:

Very common (10% or more): Hypoglycemia (when used in combination with a sulfonylurea)

Common (1% to 10%): Hypoglycemia, anorexia, decreased appetite

Uncommon (0.1% to 1%): Dehydration

Postmarketing reports: Dehydration resulting from nausea, vomiting and diarrhea[Ref]

Chronic Weight Management:

In patients with type 2 diabetes mellitus receiving this drug for chronic weight management, severe hypoglycemia occurred in 0.7% (3/422) of liraglutide-treated patients, each of these patients was also receiving a sulfonylurea. Among all patients receiving this drug in combination with a sulfonylurea, symptomatic hypoglycemia occurred in 43.6% (48/110) of patients. The dose of sulfonylurea had been reduced by 50% at the start of the trial. Among patients not taking a sulfonylurea, symptomatic hypoglycemia occurred in 15.7% (49/312) of patients.

Pediatric Studies: Clinically significant hypoglycemia occurred in 1.6% of pediatric patients (placebo=0.8%).

Type 2 Diabetes Mellitus:

Major episodes of hypoglycemia have not been reported in clinical trials in which liraglutide was used as monotherapy, however, when used in combination with a sulfonylurea, hypoglycemia was very commonly reported. Pediatric Patients: The risk of hypoglycemia was higher in pediatric patients regardless of insulin and/or metformin use.[Ref]

Nervous system

Very common (10% or more): Headache (up to 13.6%)

Common (1% to 10%): Dizziness

Frequency not reported: dysgeusia[Ref]

Respiratory

Type 2 Diabetes Mellitus:

Common (1% to 10%): Nasopharyngitis, bronchitis, upper respiratory infection[Ref]

General

The most commonly reported adverse events for this drug when used for weight management have included nausea, hypoglycemia, diarrhea, constipation, vomiting, headache, decreased appetite, dyspepsia, fatigue, dizziness, abdominal pain, and increased lipase. The most commonly reported adverse events for this drug when used to treat type 2 diabetes mellitus have included nausea, diarrhea, vomiting, constipation, dyspepsia, and decreased appetite.[Ref]

Cardiovascular

Chronic Weight Management:

Very common (10% or more): Increases in mean resting heart rate

Common (1% to 10%): Hypotension

Uncommon (0.1% to 1%): Cardiac conduction disorder, tachycardia

Type 2 Diabetes Mellitus:

Common (1% to 10%): Increased heart rate[Ref]

Chronic Weight Management:

Cardiac conduction disorders were reported as first degree atrioventricular block, right bundle branch block, or left bundle branch block. Increases in mean resting heart rate of 2 to 3 beats per minute (bpm) were observed in clinical trials. Increases of 10 and 20 bpm at 2 consecutive visits were 34% and 5% in liraglutide-treated patients versus 19% and 2% in the placebo group, respectively. Resting heart rate exceeding 100 bpm was recorded for 6% of liraglutide-treated patients versus 4% of placebo patients. Tachycardia was reported in 0.6% of liraglutide-treated patients compared with 0.1% of placebo patients. Monitoring heart rate over 24-hours found that liraglutide treatment was associated with a 4 to 9 bpm higher heart rate than placebo. The clinical significance of this is unknown. Pediatric Clinical Trials: Mean increase in resting heart rate of 3 to 7 bpm were observed.[Ref]

Genitourinary

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Common (1% to 10%): Urinary tract infection[Ref]

Local

The most common injection site reactions were erythema, pruritus, and rash at the injection site.[Ref]

Common (1% to 10%): Injection site erythema, injection site reaction[Ref]

Immunologic

Frequency not reported: Development of anti-liraglutide (the active ingredient contained in Saxenda) antibodies[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Urticaria

Postmarketing reports: Serious hypersensitivity reactions (e.g. anaphylactic reactions and angioedema), allergic reactions (rash and pruritus)[Ref]

Renal

While this drug has not been found to be directly nephrotoxic in animal studies or clinical trials, postmarketing reports of acute renal failure and worsening of chronic renal failure sometimes requiring dialysis have been received. A majority of reports occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.[Ref]

Type 2 Diabetes Mellitus:

Uncommon (0.1% to 1%): Renal impairment, acute renal failure

Postmarketing reports: Acute renal failure and worsening of chronic renal failure, sometimes requiring dialysis, increased serum creatinine[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Urticaria, pruritus[Ref]

Endocrine

Common (1% to 10%): Increased blood calcitonin levels

Uncommon (0.1% to 1%): Goiter[Ref]

Other

Common (1% to 10%): Fatigue

Uncommon (0.1% to 1%): Asthenia, malaise[Ref]

Chronic Weight Management:

Fatigue and asthenia were most commonly reported within the first 12 weeks and were often co-reported with gastrointestinal events.[Ref]

Psychiatric

Chronic Weight Management:

In adult clinical trials, 0.3% (9/3384) of patients receiving liraglutide (the active ingredient contained in Saxenda) reported suicidal ideation (placebo=0.1% [2/1941]) and 1 attempted suicide. In pediatric clinical trials, , 1 (0.8%) treated patient died by suicide; there was insufficient information to establish a causal relationship.[Ref]

Chronic Weight Management:

Common (1% to 10%): Insomnia, anxiety

Uncommon (0.1% to 1%): Suicidal ideation

Very rare (less than 0.01%): Suicide attempt[Ref]

Hepatic

Chronic Weight Management:

Uncommon (0.1% to 1%): ALT increased

Frequency not reported: AST increased

Type 2 Diabetes Mellitus:

Postmarketing reports: Elevations of liver enzymes, hyperbilirubinemia, cholestasis, hepatitis[Ref]

Oncologic

Chronic Weight Management:

Breast Cancer: During clinical trials, 0.6% (4/2379) of liraglutide-treated patients were diagnosed with breast cancer compared with 0.2% (3/1300) of placebo patients. There were too few cases to determine if these were related to drug treatment and insufficient data to determine whether this drug had an effect on preexisting breast neoplasia. Papillary Thyroid Cancer: During clinical trials, 0.2% (7/3291) of the liraglutide-treated patients were diagnosed with papillary thyroid carcinoma compared with no cases in 1843 placebo patients. Colorectal Neoplasms: During clinical trials, 0.5% (17/3291) of the liraglutide-treated patients had benign colorectal neoplasms compared with 0.2% (4/1843) of placebo patients. Malignant colorectal carcinoma was diagnosed in 2 liraglutide-treated patients.

Type 2 Diabetes Mellitus:

In clinical trials, 6 cases of thyroid C-cell hyperplasia were reported among liraglutide-treated patients and 2 cases in the comparator-treated group (1.3 vs 1 case per 1000 patient-years). Medullary thyroid carcinoma was diagnosed in 1 patient in the comparator group who had pretreatment serum calcitonin concentrations greater than 1000 ng/L suggesting preexisting disease. The study required protocol-specified serum calcitonin measurements. All cases of thyroid C-cell hyperplasia were diagnosed after thyroidectomy which was done due to abnormal calcitonin levels. Of the 6 patients with thyroid C-cell hyperplasia, 5 had elevated calcitonin concentrations at baseline and throughout the trial. One patient in both the liraglutide-treated group and the comparator group developed elevated calcitonin concentrations while on treatment.[Ref]

Chronic Weight Management:

Uncommon (0.1% to 1%): Benign colorectal neoplasms, papillary thyroid cancer, breast cancer, malignant colorectal carcinoma

Type 2 Diabetes Mellitus:

Uncommon (0.1% to 1%): Thyroid neoplasms

Frequency not reported: Thyroid C-cell hyperplasia

Postmarketing reports: Medullary Thyroid Cancer[Ref]

Frequently asked questions

References 1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0 2. Cerner Multum, Inc. "Australian Product Information." O 0 3. "Product Information. Victoza (liraglutide)." Novo Nordisk Pharmaceuticals Inc (2010): 4. "Product Information. Saxenda (liraglutide)." Novo Nordisk Pharmaceuticals Inc (2015):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

drugs.com - Saxenda Side Effects: Common, Severe, Long Term - Drugs.com

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